MANIFEST-2_NZA68438


Study of CPI-0610 in Myelofibrosis (MF) (MANIFEST-2)

Trial summary:

A Phase 3, randomized, blinded study comparing CPI-0610 and ruxolitinib with placebo and ruxolitinib in myelofibrosis (MF) patients that have not been exposed previously to Janus kinase inhibitors (JAKi).

Receptor status / problem studied:

Essential Thrombocythaemia/ Myelofibrosis/ Polycythaemia

Inclusion criteria

  • Aged ≥ 18 years
  • Confirmed diagnosis of myelofibrosis (primary, post-polycythemia vera, or post essential thrombocythemia)
  • Adequate hematologic, renal, and hepatic function
  • Have at least 2 symptoms with an average score ≥ 3 or an average total score of ≥ 10 over the 7-day period prior to randomization using the MFSAF v4.0
  • Prognostic risk-factor score of Intermediate-1 or higher per Dynamic International Prognostic Scoring System (DIPSS) scoring system
  • Spleen volume of ≥ 450 cm^3
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

Exclusion criteria

  • Splenectomy or splenic irradiation in the previous 6 months
  • Chronic or active conditions and/or concomitant medication use that would prohibit treatment
  • Had prior treatment with any JAKi or BET inhibitor for treatment of a myeloproliferative neoplasm

View more trial information

Open for recruitment

Trial Title

MANIFEST-2 CP-0610-04

Diagnosis

Myeloproliferative disorders

Type of trial

Pharmaceutical

Type of treatement

Haematology

Phase

III

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